Stay Afloat with Lessons Learned

FDA's Edwin Rivera-Martinez used an example of the Titanic to explain how pharmaceutical manufacturers need to dodge supply-chain challenges. Think of your company as a ship approaching multiple icebergs (i.e., economically motivated adulteration, contamination, shadow factories), some of them invisible underneath the water, and figure out how you can avoid hitting them and should you hit one, have a strategy for staying afloat, he said. Acting Associate Director for Drug Quality Assurance in the Center for Drug Evaluation and Research's Office of Compliance at FDA, Rivera-Martinez was speaking at the International Pharmaceutical Excipients Council regulatory conference in Washington, DC, early last month.

He went on to say that manufacturers can't rely on FDA to handle all their supplier audits. The agency doesn't have the resources to perform frequent audits or to inspect all the processes and equipment that a particular company may need to know about in detail.

Rivera-Martinez suggested industry and regulators get back to basics. He offered the 1950 Deming model that focuses on aligning processes within a system by sharing continuous feedback with suppliers, distributors, internal staff, consumers, and all parties involved in the manufacture and use of a drug product. Constant communication about where things are and how they are being affected is critical.

He pushed industry to look forward as well. "We need new ideas beyond testing," he said, referring specifically to diethylene glycol (DEG) and contamination incidents with glycerin. After a series of catastrophes, the natural gas industry figured out how to add a harmless "rotten egg" odorant to its product to alert people when a leak may be present. The pharma industry needs to come up with something similar—something as simple as an odor—to make the presence of DEG in a medical product known, Rivera-Martinez suggested. Now there's an idea to help the industry stay afloat.